Antimicrobial resistance and the guidelines of the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH).

Regulatory requirements for vaccine authorisation.

Vaccines are one of the most important tools available in the prevention and control of diseases in animals. It is therefore of the utmost importance that when vaccines are used, such use should meet with the requirements of the World Organisation for Animal Health Terrestrial Animal Health Code and must be authorised by the recognised licensing body in the country/region where the vaccines are...

The activities of veterinary vaccine control laboratories.

The activities of veterinary vaccine control laboratories are reviewed. The National Veterinary Assay Laboratory (NVAL) in Japan is used as an example to describe a quality control system for veterinary vaccines. Veterinary vaccine control laboratories conduct tests on veterinary vaccines and perform studies to improve test methods to ensure quality, efficacy and safety. The primary responsibil...

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Ich Harmonised Tripartite Guideline Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility S5(r2)

Protecting the rights of pediatric research subjects in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

This Comment argues that the parties to the International Conference on Harmonization of Technical Requirements for Regulation of Pharmaceutical Drugs (ITCH) should adopt more specific guidelines for pediatric research than those included in its Good Clinical Practice Guidelines (ICH GCP), and analyzes their attempt to do so in the Draft Guideline on Pediatric Trials. Part I of this Comment out...

Features in scientific and technical cooperation in the field of non-conventional renewable energy

This article discusses the prospects for the development of the implementation of scientific and technical cooperation. On the example of international cooperation between Ukraine and Chile, there are approaches to improving the procedure for developing cooperation priorities. The current state of these relations does not reflect real trends in the development of international economic relation...